To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on...
Date First Received: August 9, 2006
Last Updated: May 14, 2009
Verified by: Solvay Pharmaceuticals, May 2009
Clinical Trial Phase: Phase 3 | Start Date: June 2006
Overall Status: Completed
Estimated Enrollment: 482
Brief Summary
Official Title: “A Randomized, Double-Blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.”
Condition Keyword(s):
To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: December 2008
Intervention(s) in this Clinical Trial
- Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
- F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
- Drug: Metformin
- 500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- TG / HDL-C ratio
- Time Frame: 24 weeks
Safety Issue?: No
- Time Frame: 24 weeks
Secondary Measures
- Lipid and glycemic parameters
- Time Frame: 24 weeks
Safety Issue?: No
- Time Frame: 24 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.
Exclusion Criteria:
- Type 1 diabetes.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Solvay Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Global Clinical Director Solvay Study Director Solvay Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362323
Study ID Number: C LF23-0121 06 01
ClinicalTrials.gov Identifier: NCT00362323
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
